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U.S. Department of Health and Human Services

Class 2 Device Recall PIP FIXATION HINGE

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  Class 2 Device Recall PIP FIXATION HINGE see related information
Date Initiated by Firm January 23, 2009
Date Posted September 15, 2009
Recall Status1 Terminated 3 on July 29, 2013
Recall Number Z-2027-2009
Recall Event ID 52617
510(K)Number K994143  
Product Classification external fixation of finger joint - Product Code JDW
Product Smith & Nephew Orthopaedics PIP (proximal Interphalangeal) FIXATION HINGE KIT, REF 101638, for external fixation of finger joint.
Code Information All Lots
Recalling Firm/
Manufacturer
Smith & Nephew Inc
1450 E. Brooks Rd
Memphis TN 38116
For Additional Information Contact Victor Rocha
901-399-6771
Manufacturer Reason
for Recall
Hinge failure: The product is cracking or breaking during use.
FDA Determined
Cause 2
Nonconforming Material/Component
Action The Smith & Nephew Sales Representatives were notified of the problem and the recall via certified letter and e-mail on 01/23/2009. A second notice was sent to the hospitals on 06/06/2009. All affected Smith & Nephew International Distributors were notified via email on 01/23/2009. They were instructed to immediately notify their accounts concerning the recall. Smith & Nephew c/o Return Goods, 4287 Delp St, Memphis, TN 38118
Quantity in Commerce 7,089 units
Distribution Worldwide Distribution: USA, Turkey, Denmark, Germany, Malaysia, Hong Kong, Korea, Switzerland, Japan, Singapore, Canada, New Zealand, Australia, and Italy.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JDW and Original Applicant = SMITH & NEPHEW, INC.
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